Effects on sleep bruxism activity of clear aligners detected with nocturnal instrumental recordings

Effects on sleep bruxism activity of orthodontic clear aligners detected with nocturnal instrumental ECG/EMG recording: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12654415

Enrollment

Registered

2017-03-09

Start date

2014-04-20

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep bruxism Oral Health

Interventions

A group of 40 patients will be screened for sleep bruxism with a validated portable device (Bruxoff®, OT Bioelettronica, Torino, Italia) before being randomly allocated (random number list software g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients able to give their informed consent 2. Patients suffering from sleep bruxism 3. Good oral hygiene and periodontal status 4. Patients requiring orthodontic treatment 5. Adolescents (aged from 16 years) and adults (>18 years)

Exclusion criteria

Exclusion criteria: 1. Patients suffering from neurological diseases 2. Patients suffering from signs/symptoms of tempormandibular disorders 3. Patients already wearing occlusal splints 4. Patients with orthodontic treatment in progress 5. Post traumatic patients 6. Patients suffering from other sleep disorders (i.e., sleep apnea, restless leg syndrome)

Design outcomes

Primary

Measure	Time frame
Sleep bruxism index, determined from Bruxmeter software at baseline, 1 month, 3 months, 6 months, and 1 year	—

Secondary

Measure	Time frame
EMG signals (tonic, phasic or mixed), measured with dedicated software at screening, 1, 3 and 6 months, and 1 year	—

Countries

Italy

Contacts

Public ContactAndrea Deregibus

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026